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Bioengineered blood vessels for hemodialysis access successfully supported blood flow and evolved into native-like blood vessels in patients with end-stage renal disease (ESRD) participating in 2 phase 2 trials, according to new findings published in Science Translational Medicine. The investigational human acellular vessels (HAVs), developed by Humacyte Inc, are also in phase 2 trials for peripheral arterial disease and vascular trauma.
The HAVs are created by seeding donated human vascular smooth muscle cells into a tubular scaffold that degrades as the cells proliferate and produce extracellular matrix proteins. Donor cells are removed from the resulting tube-shaped tissue, leaving behind an acellular “off-the-shelf” vessel without immunogenicity.
In the new study, HAVs were implanted as arteriovenous conduits for hemodialysis access in the upper arms of 60 patients with ESRD. The researchers examined HAV samples retrieved from 13 patients from 16 weeks to almost 4 years after implant. Following implant, the patient’s own cells grew into the HAVs, forming distinct tissue layers structurally similar to those in natural human blood vessels, with no evidence of adverse inflammation or immune reaction. The vessels also exhibited signs of self-healing after dialysis needle insertion.
Currently, vascular grafts constructed from autologous, allogeneic, or xenogeneic tissues or from synthetic polymers are used to create vascular access for patients undergoing hemodialysis, but these often result in serious complications or require additional surgical procedures, according to study coauthor and Humacyte founder, Laura Niklason, MD, PhD, of Yale University. “Alternative solutions are needed to establish durable long-term vascular access for dialysis with reduced infection rates and lower complications,” she said.
Two phase 3 trials across 40 sites in the United States, Europe, and Israel are evaluating the HAVs as a conduit for hemodialysis in patients with end-stage renal disease requiring renal replacement therapy.
Abbasi J. Off-the-Shelf Bioengineered Blood Vessels Tested in Trials. JAMA. 2019;321(18):1759. doi:10.1001/jama.2019.5806
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